A Study of an Investigational Study Drug for Benign Prostatic Hyperplasia (0906-140)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00127179
First received: August 3, 2005
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

The purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with benign prostatic hyperplasia.


Condition Intervention Phase
Benign Prostatic Hyperplasia
Drug: MK0906, finasteride / Duration of Treatment: 48 weeks
Drug: Comparator: placebo / Duration of Treatment: 48 weeks
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: MK0906 Phase III Double-Blind Comparative Study - Benign Prostate Hyperplasia

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change from baseline in the International Prostate Symptom Score

Secondary Outcome Measures:
  • Change from baseline in QOL - index
  • Change from baseline in maximum urinary flow rate, %
  • Change from baseline in Prostate volume

Estimated Enrollment: 600
Study Start Date: January 2004
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Years to 79 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with benign prostatic hyperplasia

Exclusion Criteria:

  • Patients who are suspected to be suffering from prostatic cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127179

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00127179     History of Changes
Other Study ID Numbers: 0906-140, MK0906-140, 2005_042
Study First Received: August 3, 2005
Last Updated: September 12, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male

ClinicalTrials.gov processed this record on October 01, 2014